BIOTECH PATENTING - C5

20 th Forum on
Business Information
In A Global Context
BIOTECH
PATENTING
Featuring
11 in-house
perspectives
Legal and Practical Strategies for Protecting
and Leveraging your Biotech Portfolio
16-17 March 2011 | Hotel Vier Jahreszeiten Kempinski, Munich, Germany
Led by Experts from:
German Federal Court of Justice
European Patent Office
German Patent & Trademark
Office
Merck & Co
Ipsen Pharma
GE Healthcare
Biotechnology Industry
Organization
MagForce Nanotechnologies AG
Teva Europe
Merck Serono
Esteve
Novozymes A/S
Stem Cell Sciences plc
Pfizer
Ropes & Gray LLP
Daniel Advogados
Shelston IP
Boult Wade Tennant
Jones Day
df-mp
Arnold & Porter
Hoyng Monegier LLP
Vossius & Partner
Fitzpatrick, Cella, Harper & Scinto
Keynote Address:
Split Patent Litigation System and the “Angora Cat” Argument
– Dr. Klaus Grabinski, Judge, German Federal Court of Justice
Chaired By:
Immac Thampoe
Managing Intellectual
Property Counsel – Biologics
Merck & Co. Inc.
Senior counsel from leading biotech and pharma companies, patent examiners
from the EPO and German Patent Office and eminent lawyers and patent attorneys
will provide expert guidance on:
• The ongoing impact of Monsanto v Cefetra on the European biotech industry
• How the “ACLU/Myriad Genetics ‘gene patents’ case” will determine the patenteligibility
of purified nucleotides and other isolated natural substances
• The connection between software and laboratory biotechnology and the
availability of mixed patents
• How to draft “Second Medical Use”claims in light of Carvedilol II, Actavis v Merck,
G5/83 and G2/08
• How the US healthcare reforms have created a generic pathway for biologic
therapeutics
• The significance of the decision in Abbot Laboratories on failure to disclose
prior art
• Utilising genetic resources and what the new International Regime on Access
and Benefit Sharing will mean to applicants
Pre-Conference Workshops:
Giampiero De Luca
Senior Vice President,
Licensing & Intellectual
Property, Merck Serono SA
A Drafting Successful Patent Applications for Biotechnology-Related Inventions
in 2011
B Managing Due Diligence: Scrutiny of Your Patent Portfolio
Jane T. Gunnison
Partner
Ropes & Gray LLP
Associate
Sponsor:
Session Sponsors:
Media Partners:
Up to
18.75CPD
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/biotechpatenting

“The information provided during the conference is exactly what I need
to ensure the IP advice I provide to my companies is accurate.”
Marie-Pauline Ayroles, European Patent Attorney, Sanofi Pasteur
THE ESSENTIAL UPDATE ON BIOTECH PATENTING STRATEGY
Biotechnology inventions are only as valuable as their patents, and every
facet of patenting—from qualifying criteria, to the scope of rights a patent
bestows, to the length of a patent’s duration—is becoming increasingly
complex as patent law evolves to keep pace with biotech innovation.
With patent standards constantly in flux, it is essential that you have
up-to-the-minute information on how best to protect your biotechnology
inventions; from meeting qualifying criteria, to working with patent examiners
to achieve the best results possible, to maximising the scope of rights a patent bestows.
If you are involved in drafting biotech patent applications or protecting them, C5’s market leading
conference is developed with you in mind. Our 20 th edition of Biotech Patenting in Europe will give you
up-to-the-minute information to make sure your patents are rock solid. You will receive expert analysis,
case law insights from Europe and the US to make sure you have the best strategy in place to manage
the new challenges in Biotech Patent Practice.
You requested it in 2010’s conference feedback and for 2011 we have delivered:
• Even more case-studies and practical examples: 11 in-house perspectives from the world’s
leading Biotech and Pharma companies
• Conference Workbooks: a printed pack of session materials allowing you to take notes at the
event and use back at the office
• Real life examples of claims which are rejected and why: from the EPO and German Patent Office
• More Q&A opportunities: extended session times to allow discussion and interaction with delegates
• Enhanced networking opportunities: longer breaks to discuss key issues with fellow delegates
and speakers
In addition, our expert-led post-conference workshop on Drafting Successful Patent Applications
for Biotechnology-Related Inventions in 2011 and Managing Due Diligence: Scrutiny of Your Patent
Portfolio will provide guidance on how to develop your patenting strategy in this complex and rapidly
shifting area.
Be where your industry will be on 16 th and 17 th March 2011.
“I would recommend the conference to my colleagues. I have found it very useful for updating
my knowledge and understanding better the case-law relating to biotech invention.”
Cristina Biggi, Patent Attorney, Bugnion SPA
ASSOCIATE SPONSOR
Global law firm Ropes & Gray, with 1,000 attorneys in nine offices on three continents, is the recipient of the 2010 Chambers USA “Award for
Excellence” as the preeminent intellectual property practice in the US. From patent and trademark protection to “bet the company” litigation, we
work collaboratively with our clients to create the strategies that lead to their success.
SESSION SPONSOR
Daniel Advogados Intellectual Property Firm offers its clients all the advantages of a specialized and comprehensive intellectual property service,
combining the benefits of experience and constant modernization. Our highly qualified professionals guarantee the competence and flexibility
necessary to achieve the best results in:
• Trademarks
• Patents for Inventions and Utility Models
• Registration of Industrial Designs
• Protection for Computer Programs
• Registration of Domain Names
• Trade Dress Protection
• Internet Rights
• Repression of Unfair Competition
• Combating of Piracy
• Transfer of Technology and License Agrements
• Licensing And Franchise Contracts
• Litigation

A
9.00am
to 12.00pm
Drafting Successful Patent Applications
for Biotechnology-Related Inventions in 2011
Dr. Christian Paul, Partner, Jones Day
Dr. Martin Weber, Partner, Jones Day
Thomas Ritter, Ph.D., European Counsel, Jones Day
Dr. Christian B. Fulda, European Counsel, Jones Day
The drafting of patent applications covering biotechnology relate
inventions such as research tools, pharmaceuticals, genomics, proteomics
and diagnostics is becoming increasingly complex, given the changing
legal and regulatory landscape. Moreover, the rapidly evolving science
and technology in this area makes it imprudent to rely upon yesterday’s
‘tried and true’ drafting methods.
The workshop leaders will walk you through the process of drafting the
claims and specifications for these increasingly complex applications, and
provide you with the tools you need to draft strong applications that will be
well positioned to withstand future challenges. Topics to be covered include:
• What the examiners are looking for
• What you should include – and avoid – in drafting a successful
patent application in light of evolving case law and standards
• How to address European and Federal Circuit case law in your
application proactively
• When to file broad and when to file more narrow claims
• Whether claims of differing scope should be filed in the same
or separate applications – impact of new EPO limitations on
divisional applications
• Claim categories: How to ensure a broad scope of protection
(purpose-limited / Swiss claims, national requirements, dosage
regimens)
• Preparing in advance for search limitations – impact of new
EPO practice
• Enablement and written description – anticipating and defending
against attacks arising from these changing requirements
• What are we to do about biological products (nucleic acids,
proteins, antibodies) that at the time of filing, can only be
described functionally and not structurally
• What to consider when claiming diagnostic methods in view
of recent Enlarged Board of Appeal decisions
• How can Bilski affect claim drafting for biotechnological
inventions in the US
In addition, the workshop will cover issues that should be considered when
drafting claims in the context of litigating or licensing patent claims related
to biotechnology inventions to help you prepare patents and structure deals
that provide real value. Points of discussion will include:
Pre-Conference Workshops – 15 th March 2011
B
1.00pm
• Consideration of claim language – how to permit the patentee
to meet the burden of proving infringement without unnecessary
difficulty
• Products and processes – do claims cover those products or
processes that will be commercialised
• Doctrine of equivalents – how to determine infringement, how
to build the basis for an enlarged scope of protection
Patent practitioners will benefit from these experienced perspectives and
this hands-on approach, which will help participants not only prepare
patent applications but also structure deals that will exploit the value
resulting from these strong patents.
to 4.00pm
Managing Due Diligence: Scrutiny of Your Patent Portfolio
Dr. Christian Paul, Partner, Jones Day
Dr. Martin Weber, Partner, Jones Day
Thomas Ritter, Ph.D., European Counsel, Jones Day
Dr. Christian B. Fulda, European Counsel, Jones Day
Preparing your company’s portfolio for due diligence is key if you are to
conclude successful transactions. Failure to scrutinise your patent estate,
with the eyes of a potential partner/acquirer, could lead to a reduction in
the value you obtain or worse, no deal at all. This workshop will focus on
the key areas you need to consider, using case studies, to make sure that
you are ready for the next time you are subject to due diligence. Areas to
be covered will include:
• Presenting your patents in the best way to secure a deal
• Do your patents adequately cover your key products and technologies
• Are your patents valid and are you ready for the validity issues
which might be raised by the other side
• Do you need to consider different approaches to validity in
different countries
• Are there any FTO issues and if so how do you plan to deal
with them
• Disclosure of FTO opinions, when can you/should you and
what are the alternatives to disclosure
• Do you have clear chain of title to the key IP If not can you
correct any defects now
• Have you anticipated the difficult questions and your answers
to them
Main Conference Day One – 16 th March 2011
9.00 Chair’s Opening Remarks
Immac Thampoe, Managing Intellectual Property Counsel
– Biologics, Merck & Co. Inc. (New Jersey, U.S.A.)
9.15 KEYNOTE ADDRESS
Split Patent Litigation System and the “Angora Cat”
Argument
Dr. Klaus Grabinski, Judge, German Federal Court of Justice
9.45 The EPO’s Perspective on Patenting Biotechnological
Inventions
Dr Aliki Nichogiannopoulou, Examiner – Biotechnology,
European Patent Office
• The legal framework for patenting biotechnological inventions
- Biotechnology: just another area of technology
• Article 53 EPC: Exceptions to patentability
• Directive 98/44/EC
• Pending Case Law relating to Article 53 EPC
• Patentability of embryonic stem cells I
- G2/06 and current practice of the EPO
• Patentability of embryonic stem cells II
- Referral to the ECJ
10.30 Morning Refreshments
Key European Biotech Cases and Landmark Decisions
Affecting Biotech Patent Practice
11.00 National Courts
Christopher Stothers, Partner, Arnold & Porter (UK)
Bart van den Broek, Partner, Hoyng Monegier LLP
(The Netherlands)
Hans-Rainer Jaenichen, Partner, Vossius & Partner (Germany)
• General trends and landmark decisions that impact your patent
strategy from leading European jurisdictions on leading issues
including:
- claims, priority entitlement and obviousness in claims
- obviousness
- validity of selection patents
- differing approaches to novelty where prior art contains errors
- exclusions from patentability
- paediatric extension
12.00 EPO Case Law
André Bourgouin, VP of Corporate IP, Ipsen Pharma
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/biotechpatenting

12.45 Lunch
• Recent Decisions of the Enlarged Board of Appeal (EBA)
- Dosing regimens G2/08 (19/2/2010) – Not followed by
decision in France (TGI Paris 28/9/2010)
- Patentability of surgical treatments G01/07 (15/2/2010)
• Referrals pending before the EBA
- Patentability of biological processes (G2/07 - G1/08)
- Disclaimers G2/10 (T1068/07 - T1107/06)
• Decisions of TBAs
- Double patenting (T1423/07)
- Industrial application/post-published evidence/parallel
proceedings (T18/09) – to be compared with UK Court
of appeal decision 9/2/2010
13.45 How Patents with Functional Claims will Stand up to
Prosecutions at the EPO and in National Courts in Europe
David Ricol, Senior Patent Attorney, Pfizer
• Case law and practice at the EPO regarding examination
of functional claims
• Assessing how well patents with broad functional claims will
stand up in examination (in prosecution)
• Evaluating how functional claims will be considered by
national courts in Europe going forward
14.15 Assessing the Eligibility and Enforcement of Patents
on DNA and Biomarker-Based Diagnostic Methods
Ian Bryan, IP Counsel, GE Healthcare
Hans Sauer, Deputy General Counsel for Intellectual
Property, Biotechnology Industry Organization
US Considerations
• Analysing the continued relevance of the “machine-ortransformation
test” to diagnostic method claims in light
of the U.S. Supreme Court’s remand after Bilski v. Kappos:
- Prometheus Laboratories v Mayo Clinic
- Classen v Biogen et al (Section 101 case)
• What impact will the ongoing litigation, and ultimate disposition
of Association for Molecular Pathology et al. V. USPTO et al. (the
“ACLU/Myriad Genetics ‘gene patents’ case” relating to BRCA1
and BRCA2) have in determining the patent-eligibility of purified
nucleotides and other isolated natural substances
European Considerations
• Patenting Biomarkers
- industrial applicability criterion for genetic inventions
- Eli Lilly v Human Genome Sciences
• The Court’s Ruling in Monsanto v Cefetra
- the Court’s construction of the Biotech Directive
- scope of protection of genetic inventions:- absolute
protection v purpose-bound protection
- what is the impact likely to be for the European biotech
industry
15.05 Gene Patenting Debate in Australia: New Bill to Ban
Patenting of “Biological Material”
Jacinta Flattery-O’Brien, Partner, Shelston IP
• Progress in the Australian Myriad Genetics BRCA gene case
• Report of Senate Inquiry into Gene Patenting
• Australian Patent Amendment (Human Genes and Biological
Materials) Bill, 2010
- the controversial definition of “biological materials”
• Is it possible that Australia will lead the way
15.35 Afternoon Refreshments
15.50 Predicting Screening Methods: The Interconnection
between Biotechnology, Nanotechnology and Software
Christoph Rehfuess, Director of Intellectual Property,
MagForce Nanotechnologies AG
• Assessing the connection between software, nanotechnology
and laboratory biotechnology
- what is the availability of mixed patents
• Computer implemented applications
- what are the consequences of the European Parliament
the Commission’s failure to come to an EU directive for
computer implemented inventions
i. how will this influence patent applications in the field
of bioinformatics
ii. what lead can be taken from the US
• data mining
iii. connection with therapy outcome in cancer treatments
• stem cell developments in the UK
16.35 Analysing National Cases Relating to the Patentability
of Second Medical Use Claims and Dosing Regimens
Fiona Bor, Senior Patent Counsel, Teva Europe Patent
Department
• Patentability of dosing regimens
• National cases relating to dosage regimes
- Actavis v Merck: the English Court of Appeal follows
T1020/03
- Carvedilol II: a much misunderstood decision from the
German Federal Supreme Court
• How to draft claims in light of Carvedilol II, Actavis v Merck,
G5/83 and G2/08
• How to draft international applications
• How might the decisions impact proceedings before the
national courts
17.15 Chair’s Closing Remarks and End of Day One
Main Conference Day Two – 17 th March 2011
9.00 Chair’s Opening Remarks
Giampiero De Luca, Senior Vice President, Licensing
& Intellectual Property, Merck Serono SA
Jane T. Gunnison, Partner, Ropes & Gray LLP
9.15 Maximising Patent Protection through Supplementary
Protection Certificates
Nicolas Vincent Ruiz, European Patent Attorney, Esteve
Sandra Pohlman, Partner, df-mp
• Assessing the varying approaches of EU jurisdictions to:
- the definition of “product” within the meaning of the
SPC Regulation
- the “first authorisation to place a product on the market”
- the specific case of “combination products”
- paediatric SPC extension: can applicants obtain a negative
or zero SPC
US Biotech Update
10.00 Inequitable Conduct after Therasense and the Impact
of Failure to Disclose
Bradford J. Badke, Partner, Ropes & Gray LLP
• U.S. Federal Circuit en banc rehearing on inequitable conduct
in Therasense (Abbott Laboratories) v. Becton Dickinson
- What is the significance of the decision on failure to disclose
material information
- Should the materiality-intent-balancing framework for
inequitable conduct be modified or replaced
- Is the “but for” standard an improvement
- What role should the U.S. Patent Office’s rules play in
defining materiality
- What is the proper intent standard
- What impact will any new inequitable conduct standard have
on the strength of U.S. patents, the behavior of practitioners,
and courts deciding the issue
Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting

10.45 Morning Refreshments
11.05 Biotech Patenting Strategies in Brazil
Rana Gosain, Partner, Daniel Advogados
• Recent guidelines on sequence listings of biotech applications
• Assessing the Brazilian PTO’s patentability position on
biotech inventions
• Update on pipeline patents: pharma/biotech inventions
• The risk of submitting amendments after substantive
examination has been filed
• ANVISA (National Health Surveillance Agency)
- second-tier examination and competence of jurisdiction
- PTO and ANVISA
11.40 Follow-on Biologics Legislation and the US
Healthcare Reforms
Raymond R. Mandra, Partner, Fitzpatrick, Cella, Harper
& Scinto
• How has this created a generic pathway for biologic
therapeutics in the US
- what is the impact on European biosimilars
• When do companies need to file for their own Biologic
License Application (BLA) approval from the Food and Drug
Administration
- can BLA applications be filed now on existing drugs or should
they be piggy backed on some innovators clinical data
- how will this statute affect how litigation will be conducted
between innovators and generics in the biologics space
12.25 How to Deal with Biological and Genetic Material
in Patent Applications
13.00 Lunch
Bo Hammer Jensen, Senior Patent Counsel, Novozymes A/S
Chair of ICC task force on Patent disclosure requirements
relating to genetic resources and traditional knowledge
• When are you dealing with biological/genetic materials
• Do you have relevant information
• Should you deposit material
• Rules and traps in relation to deposits
• Disclosure of origin of genetic resources in patent applications
• Analysing varying European rules on mandatory disclosure
- what types of rules are in existence
• The new International Regime on Access and Benefit Sharing
- what requirements does the International Regime require
from Member States
- what will this most likely mean to applicants
14.15 Examining the Relationship Between Patents
on Biological Material and Synthetic Biology
Reiner Spieker, Patent Examiner, German Patent
& Trademark Office
• History of embedding IP rights concerning living entities
in the EPC
• Invention of coal tar dyes and patents for the control of
organic synthesis pathways
• Microbial products and patenting of microorganisms; the
decisions “Red Dove” and “Baker´s Yeast” of the German
Federal Court of Justice
• Genetically modified microorganisms and multicellular
organisms
- Rule 27 EPC
• Breeding methods; “Broccoli Patent” and “Tomato Patent”
- genome-based breeding
• EU Biotechnology Directive 98/44/EC; introduction of the
terms “Biological Material” and “Genetic Information”
- what is the connection to Synthetic Biology
• Scope of Protection of patents concerning Biological Material
and of patented DNA sequences as such
- C-377/98 (Annulment of Directive 98/44/EC)
- C-428/08 (Monsanto v. Cefetra) of the European Court
of Justice
15.00 How Recent Decisions Will Affect the Ability
to Claim Antibodies
Jane T. Gunnison, Partner, Ropes & Gray LLP
Nina White, Partner, Boult Wade Tennant
• Antibody patenting in Europe
- an allowable form of reach-through claim
- establishing novelty in antibody claims - burden of proof
- obviousness – can a new antibody to a known antigen still
be inventive
- drafting antibody claims to maximise chances of success
• US case pending, Centocor v Abbot Laboratories on the
antibodies that recognise “Tumor necrosis factor”
- analysing the Ely Lilly Amicus Brief at the Federal Circuit level
▪ exploring exceptions to the written description law for
antibodies
▪ describing a number of anti-bodies to an antigen to be
able to monopolise all anti-bodies to the antigen
• How Ariad Pharmaceuticals v Eli Lilly & Co will impact on
written description requirements
• Complying with Federal Circuit ruling on written description:
- must provide sufficient disclosure in the application
- ensure the inventor had possession of the claimed subject
matter at the time of filing
• How the antigen is an exception to the written description
law that otherwise applies to nucleic acids, proteins and other
biological molecule
15.45 Afternoon Refreshments
16.00 Biotech Patenting in China: Tips, Tricks and Pitfalls
Michael Wise, Partner, Perkins Coie
• Exploring the differences between the patent systems and
recent amendments to the Chinese Patent Law
• What are the requirements for reward and remuneration
of inventors under Chinese law
• Understanding the dual system of IP enforcement in China
• Patent enforcement in China: perceptions and realities
16.45 How Contrasting National Approaches are Affecting
the Stem Cell Patent Landscape
George Schlich, Director, Schlich & Co
IP Counsel, StemCells, Inc
• What is the potential for achieving harmonisation of stem
cell patenting and examination proceedings
- what divergence is there in particular between German,
UK and other regimes
• What will be the impact of the ECJ proceedings pending
on stem cells
- Prof. Dr. Oliver Brüstle v Greenpeace e.V. C-34/10
- awaiting an ECJ definition on an embryo in light of the
EU Biotechnology directive 98/44/EC
- what is meant by the expression ‘uses of human embryos
for industrial or commercial purposes’
- does it include any commercial exploitation within the
meaning of Article 6(1) of the Directive, especially use for
the purposes of scientific research
17.15 Chair’s Closing Remarks and End of Conference
GLOBAL SPONSORSHIP OPPORTUNITIES
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Institute (ACI) and in Toronto, The Canadian Institute (CI), works closely
with sponsors to create the perfect business development solution catered
exclusively to the needs of any practice group, business line or corporation.
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the US and Canada, C5, ACI and CI provide a diverse portfolio of first-class
events tailored to the senior level executive.
For more information about this program or our global portfolio, please contact:
Jo Menzer on +44 (0)20 7878 6978 or email j.menzer@C5-Online.com
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/biotechpatenting
©C5, 2010

20 th Forum on
BIOTECH PATENTING
Legal and Practical Strategies for Protecting and Leveraging your Biotech Portfolio
Business Information
In A Global Context
Priority Service Code
584L11.WEB
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Date: 16 – 17 March, 2011
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